Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis (EndoStatin)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Poznan University of Medical Sciences.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Poznan University of Medical Sciences
Collaborators:
University of California, Davis
Biomet Polska Sp. z.o.o.
Information provided by:
Poznan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00675779
First received: May 5, 2008
Last updated: May 9, 2008
Last verified: May 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine whether atorvastatin (alone or in combination with oral contraceptive) is effective in treatment of pelvic pain and inflammatory response in women with endometriosis.
| Condition | Intervention |
|---|---|
|
Endometriosis Pain |
Drug: oral contraceptive (Mercilon) Drug: atorvastatin + oral contraceptive |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Pain Relief and Inflammatory Status in Women With Surgically Confirmed Endometriosis Treated With Atorvastatin, Oral Contraceptive or Combined Oral Contraceptives and Atorvastatin: Open Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Poznan University of Medical Sciences:
Primary Outcome Measures:
- pain relief [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- inflammatory status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 44 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 2
oral contraceptive + atorvastatin
|
Drug: atorvastatin + oral contraceptive
atorvastatin 20mg po a day for 6 months + oral contraceptive (20ug EE, 150ug DSG) 1 tablet po a day for 21 days with 7 day break for 6 months
Other Name: Atrox 20 (Biofarm sp. z o.o. , Poznan, Poland)
|
|
Active Comparator: 1
oral contraceptive
|
Drug: oral contraceptive (Mercilon)
oral contraceptive (20ug EE, 150ug DSG) 1 tablet a day p.o. for 21 days with 7 day break for 6 months
Other Name: Mercilon (Organon Schering-Plough, Poland)
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- informed written consent
- premenopausal women aged 18-45
- clinical signs and symptoms of endometriosis for minimum 3 months with endometriosis confirmed at laparoscopy or laparotomy within last 4 months - 5 years (preferably with histological confirmation)
- pain symptoms of moderate intensity (dysmenorrhoea + dyspareunia + nonmenstrual pelvic pain > 6 points on Biberoglu & Behrman scale [1981])
- no clinical signs of sexually transmitted disease
Exclusion Criteria:
- cancer of the ovary, adrenals, endometrium, uterine cervix, breasts
- pregnancy or lactation
- unexplained uterine/cervical bleeding
- hormonal therapy within last 3 months (for GnRH analogs 6 months)
- irregular menses (> 35 days) or secondary amenorrhoea (>3 months)
- other chronic disease affecting pelvic or abdominal cavity (including PID, ulcerating colitis , Crohn's disease, recurrent interstitial cystitis)
- sexually transmitted disease (gonorrhoea, Chlamydia)
- uncontrolled diabetes mellitus type I or II, VTE or other contraindications to medicine used in the study
- chronic therapy with CYP3A4 inhibitors (including ketoconazole, erythromycin and others)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00675779
Locations
| Poland | |
| Poznan University of Medical Sciences, Department of Gynecology and Obstetrics | |
| Poznan, Poland, 60-535 | |
Sponsors and Collaborators
Poznan University of Medical Sciences
University of California, Davis
Biomet Polska Sp. z.o.o.
Investigators
| Study Chair: | Antoni J Duleba, MD | University of California, Davies, USA |
| Study Director: | Leszek Pawelczyk, MD PhD | Poznan University of Medical Sciences, Poland |
More Information
No publications provided
| Responsible Party: | Robert Z. Spaczynski, MD PhD, Poznan University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT00675779 History of Changes |
| Other Study ID Numbers: | 204-08 |
| Study First Received: | May 5, 2008 |
| Last Updated: | May 9, 2008 |
| Health Authority: | Poland: Ministry of Health |
Keywords provided by Poznan University of Medical Sciences:
|
endometriosis atorvastatin oral contraception |
pain relief pelvic pain in women with endometriosis |
Additional relevant MeSH terms:
|
Endometriosis Pelvic Pain Genital Diseases, Female Pain Signs and Symptoms Contraceptive Agents Contraceptives, Oral Contraceptives, Oral, Combined Atorvastatin Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents |
ClinicalTrials.gov processed this record on June 18, 2013